Chapter 2: Indications For Use And Safety; Statement; Indications For Use; Important User Information - Dexcom G4 Platinum User Manual

CHAPTER 2: INDICATIONS FOR USE AND
SAFETY STATEMENT

2.1 INDICATIONS FOR USE

The Dexcom G4 PLATINUM (Pediatric) Continuous Glucose
Monitoring System is a glucose monitoring device indicated
for detecting trends and tracking patterns in persons ages 2
to 17 years with diabetes. The system is intended for single
patient use and requires a prescription.
The Dexcom G4 PLATINUM (Pediatric) System is indicated
for use as an adjunctive device to complement, not
replace, information obtained from standard home glucose
monitoring devices.
The Dexcom G4 PLATINUM (Pediatric) System aids in the
detection of episodes of hyperglycemia and hypoglycemia,
facilitating both acute and long-term therapy adjustments,
which may minimize these excursions. Interpretation of the
Dexcom G4 PLATINUM (Pediatric) System results should
be based on the trends and patterns seen with several
sequential readings over time.

2.2 IMPORTANT USER INFORMATION

Please review your product instructions before using
your continuous glucose monitoring system. Indications,
contraindications, warnings, precautions, cautions, and other
important user information can be found in your product
instructions. Discuss with your healthcare professional
how you should use your sensor trend information to help
manage your diabetes. Your product instructions contain
important information on troubleshooting your system and on
the performance characteristics of the device.
Dexcom G4 PLATINUM (Pediatric) System User's Guide | 21